MEETING THE UNIQUE CHALLENGES OF PHASE 4 TRIALS…SUPPORTING THE FUTURE
PROMETRIKA’s comprehensive phase 4 services focus on helping our sponsors in their efforts to build product awareness, investigate new indications, and fulfill post-marketing regulatory commitments.
Post-marketing research requires a sharp focus on efficiency and on maximizing return on investment for sponsors. PROMETRIKA has designed fit-for-purpose protocols for collection of real-world data (RWD) and completed the analyses supporting real-world evidence (RWE) for sponsors’ programmatic needs.
PROMETRIKA has the necessary methodologies and perspectives required to meet the unique challenges in the design and implementation of post-marketing strategies.
FDA Guidelines
The FDA has developed a number of draft guidances on data sources, data standards, and regulatory considerations for the use of RWD and RWE. PROMETRIKA’s expert biostatisticians and clinical operations leadership are familiar with these guidances and have applied the principles therein to our sponsors’ clinical development agendas.
Methodologies & experiences
Equally important to post-marketing activities is developing the necessary methodologies and perspectives required to meet the unique challenges of design and implementation of phase 4 commitments. For more than 20 years, PROMETRIKA has worked closely with medical affairs and marketing teams in large and small biopharmaceutical companies, assisting with successfully meeting these challenges.
OUR SERVICES
- Comparative head-to-head studies with equivalence or non-inferiority endpoints
- Non-randomized observational studies and patient registries
- Special safety studies to fulfill phase 4 regulatory commitments
- Observational marketing research
- Post-marketing safety update reports for regulatory submission
- Exploratory statistical analyses of data from marketing authorization clinical trials
- Awareness building, medical education and publication support
- Editorial services related to abstracts, posters, manuscripts, and scientific meeting presentations